We all take the common fridge for granted. At home it keeps the beer cold and the milk fresh, in pharmacies industrial sized fridges keep our vaccines potent. But what if you live in a country where infrastructure is poor, fridges a luxury and electricity unreliable?

Vaccines are fragile biologicals products. To ensure their full efficacy, the cold chain must be respected every step of the way, including the production of the vaccine and the successive storage and transportation phases, through to the moment it is administered. Maintaining a vaccine at the required +2°C to 8°C to keep it potent until it is administered can be a difficult requirement and a big challenge in countries where cold chain requirements are weak. These difficulties are one of the main causes of low rates of vaccination.

The cholera vaccine from Shantha Biotechnics aims to overcome this obstacle as it can now be kept at ambient temperatures of up to +40°C for up to 14 days immediately prior to administration, which will improve populations’ access to the vaccine in Asia and Africa, where it is mostly used. The use of this cholera vaccine in a controlled temperature chain (CTC) was granted by the World Health Organization (WHO) in February.

“This is a significant milestone in our efforts towards effective cholera prevention and control. The WHO’s approval will help us make our vaccine available to populations living in remote, hard-to-reach areas of India and other parts of the world, especially ones with erratic electricity supply,” says Dr. Mahesh Bhalgat, Executive Director and Chief Operating Officer of Shantha Biotechnics, an affiliate of Sanofi Pasteur in India.(1)

Freeing up time maintaining the cold chain builds in a whole new flexibility that will help improve delivery of Shantha’s cholera vaccine and increase efficiency of mass vaccination campaigns, whether they occur in urban centers, rural areas, or outermost regions, by reaching more people.

“Cholera is an easily preventable disease that has no place in the 21st century,” says Anuradha Gupta, Deputy CEO of Gavi, the Vaccine Alliance. “This important development will make it easier to deliver vaccines to the remote areas where it is desperately needed, saving lives and contributing to the global effort to finally consign this disease to the history books.”

Humanitarian and international organizations have to respond to multiple cholera outbreaks causing havoc and deaths in communities already hit by poverty, conflict, or natural disasters.[2] Since WHO pre-qualification in 2011, 12 million doses of Shantha’s vaccine have been shipped to 25 countries across the world, including Democratic Republic of the Congo, Haiti, Mozambique, and South Sudan. The largest ever shipment took place in September 2017 when Shantha responded to an urgent call for humanitarian help from international agencies and sent 900,000 doses to Nigeria to respond to the country’s cholera epidemic.

(1) Shantha Biotechnics, an affiliate of Sanofi Pasteur in India, is a fully integrated biotechnology company involved in R&D, manufacturing and marketing. Shantha was founded by Dr. K I Varaprasad Reddy in 1993 in Hyderabad. Sanofi Pasteur is Sanofi Vaccines Global Business Unit.

(2) Several large-scale outbreaks, surges in endemic cholera, and multiple humanitarian emergencies have recently occurred in many parts of the world, including Burundi, Guinea-Bissau, Haiti, Kenya, Malawi, Mozambique, Nigeria, South Soudan, Tanzania, Zambia, and just recently in the Democratic Republic of Congo and in Yemen.